A5433: Long-Acting Lenacapavir and Cabotegravir in Low- and Middle-Income Countries

Active, Not Recruiting

Phase IIIb, Randomized, Multicenter, Open-Label Strategy Trial to Evaluate the Efficacy, Safety and Tolerability of Dual Long-Acting (LA) Lenacapavir (LEN) and Cabotegravir (CAB) in Adolescents and Adults with Virologic Failure on Tenofovir/Lamivudine/Dolutegravir (TLD) in Low-and Middle-Income Countrie

Treatment Category

HIV Treatment, Treatment Experienced

Study Description

The current guidelines recommend that people living with HIV should take HIV medication, such as Tenofovir/Lamivudine/Dolutegravir (TLD), daily by mouth throughout their whole lives. This is important to keep the amount of the virus in the body well controlled so that they can live long, healthy lives. However, for many people, especially adolescents and postpartum women, taking pills every day is hard.

Study Purpose

The study aims to find out how well long-acting injectable medicines work to keep HIV under control compared to taking daily pills in people who struggle to take the pills. The study will find out how safe and easy it is to use injections (Cabotegravir (CAB) given every 2 months and Lenacapavir (LEN) given every 6 months) compared to the usual daily pills.

Target Participant

  • People aged 16 or older living with HIV, and
  • Have been on oral TLD (or similar medications allowed by the protocol) for at least 48 weeks prior to entry into the study, and
  • Have trouble taking their daily oral HIV medicine. This is shown by high levels of virus in the blood.

Study Details

At study entry, you will be randomly assigned into one of two groups:

  • The first group will receive long-acting injectable treatment: LEN-LA injections will be given every 6 months and CAB-LA injections given every 2 months.
  • The second group will continue taking their daily HIV medication by mouth, with additional counseling to enhance adherence.

Treatments Or Drugs Involved With Study

  • The first group will have Lenacapavir (LEN) Long-Acting (LA) injections given every 6 months and Cabotegravir (CAB) Long-Acting injections given every 2 months.
  • The second group will continue taking their daily HIV medication by mouth.

Duration Of Study

Participants will be in this study for 96 weeks.

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